Events

Recall of Desflurane Vaporizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73959
  • Event Risk Class
    Class 2
  • Event Number
    Z-1812-2016
  • Event Initiated Date
    2016-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145674
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vaporizer, anesthesia, non-heated - Product Code CAD
  • Reason
    Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. eye contact with volatile anesthetics can result in serious irritation. immediate eye flushing and consultation of a physician is recommended. updated material safety data sheets (msds) for desflurane recommend wearing safety glasses when handling these substances.
  • Action
    Drager mailed a "Medical Device Safety Alert" dated April 21, 2016, to customers informing them of the problem and provided instructions for the "correct filling procedure" and recommendations on how to prevent evaporation and spraying of Desflurane after bottle release to resolve the "High Friction of gas bottle valve" problem.

Device

Desflurane Vaporizer
  • Model / Serial
    Catolog Number M35500 (D-Vapor) M36700 (D-Vapor 3000) Distributed October 2004  April 2016
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide distribution, including Puerto Rico and Guam.
  • Product Description
    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA